check_circleStudy Completed

Osteoarthritis

Bayer Identifier:

19649

ClinicalTrials.gov Identifier:

NCT03330288

EudraCT Number:

Not Available

EU CT Number:

Not Available
Prospective multicenter non-interventional study in patients with knee or hip osteoarthritis having a Theraflex treatment

Trial purpose

The main purpose of this study is to evaluate how a long-term treatment with Theraflex during 64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily living, the quality of life and patient satisfaction with treatment.

Key Participants Requirements

Sex

All

Age

45 - 75 Years
  • - Patients 45 to 75 years with Hip or Knee OA stage I to III
    - Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
    - Personally signed and dated informed consent
  • - Patients participating in an investigational program with interventions outside of routine clinical practice
    - Patients with Hip or Knee OA stage 0 or stage IV
    - Patients who have both Hip and Knee OA and OA of any other location
    - Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
    - Females who are pregnant or breastfeeding
    - Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment
    - Patients who completed intra-articular corticosteroids treatment in the last 3 months to exclusion criteria
    - Patients who completed hyaluronic injections of the lower limbs in the last 6 months

Trial summary

Enrollment Goal
1110
Trial Dates
November 2017 - July 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Theraflex® (Glucosamine hydrochloride/Chondroitin sodium sulfate, BAY874017)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Russia
Completed
Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMSMoscow, 115522, Russian Federation

Primary Outcome

  • Changes in quality of life assessed by Knee injury and Osteoarthritis Outcome Score (KOOS) in patients with knee OA
    Changes in pain, other symptoms, functions and knee related quality of life assessment will all be collected by KOOS questionnaire
    date_rangeTime Frame:
    Up to 64 weeks
  • Changes in quality of life assessed by Hip injury and Osteoarthritis Outcome Score (HOOS) in patients with hip OA
    Changes in pain, others symptoms, functions and hip related quality of life assessment will all be collected by HOOS questionnaire
    date_rangeTime Frame:
    Up to 64 weeks

Secondary Outcome

  • Drug utilization of Theraflex therapy
    as reported by the patient to their physician
    date_rangeTime Frame:
    Up to 64 weeks
  • Patient satisfaction measured with a Likert response scale
    measured with a Likert response scale (from 1-very dissatisfied to 5 – very satisfied)
    date_rangeTime Frame:
    Up to 64 weeks
  • Painkiller usage - type
    date_rangeTime Frame:
    Up to 64 weeks
  • Painkiller usage - length
    date_rangeTime Frame:
    Up to 64 weeks
  • Painkiller usage - frequency
    date_rangeTime Frame:
    Up to 64 weeks
  • Other medical/physical therapy usage-type
    date_rangeTime Frame:
    Up to 64 weeks
  • Other medical/physical therapy usage-frequency
    date_rangeTime Frame:
    Up to 64 weeks
  • Other medical/physical therapy usage-length
    date_rangeTime Frame:
    Up to 64 weeks

Trial design

Prospective multicenter non-interventional study in patients with knee or hip osteoarthritis having a Theraflex® treatment to evaluate changes in pain, functions in daily living, and quality of life for an observation period up to 64 weeks
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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